Summary:
Summary Statement of Deficiencies D0000 An announced validation survey of the laboratory was conducted on 04/10/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted CMS-209 form, review of laboratory policy, review of the laboratory's personnel records, and confirmed in interview, the technical consultant failed to evaluate the competency of three of three testing persons performing moderate complexity testing in 2024. Findings include: 1. Review of the laboratory's submitted CMS-209 form determined there was one technical consultant and three testing persons. 2. Review of the laboratory's policy titled "Personnel Training and Competency", approved by the laboratory director on 09/12/2022 stated: "Annual Evaluation and Competency ...The Laboratory Director or Technical Consultant will address the competency of each individual to fulfill the duties and responsibilities of their position including assessment of actual test performance and interpretation of results." 3. Review of the laboratory's personnel records determined competency was performed in 2024: a. Testing person-1 Date: 08/28/2024 Frequency: Yearly Evaluator: Not listed on CMS-209 form b. Testing person-2 Date: 08/28/2024 Frequency: Yearly Evaluator: Testing person-1 c. Testing person-3 Date: 08/28/2024 Frequency: Yearly Evaluator: Testing person-1 Further review of the laboratory's personnel records determined Testing person-1 failed to meet the qualifications of a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- technical consultant. 4. Testing person-1 confirmed the findings in an interview on 04 /10/2025 at 1110 hours in the office. Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --